NCT06099678

Brief Summary

The goal of this clinical trial is to determine the effect of maximal mental effort combined with elastic band training on strength and neuromuscular function in healthy, older females. The main questions it aims to answer are:

  • Does elastic band training in combination with maximal mental effort increase strength more than elastic band training alone?
  • Does elastic band training in combination with maximal mental effort improve neuromuscular function more than elastic band training alone? Participants will be randomly assigned to 1 of 3 groups:
  • Elastic band training
  • Elastic band training with maximal mental effort
  • Control Researchers will compare groups to determine differences in changes in strength, neuromuscular function, and body composition.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

October 19, 2023

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in bicep curl strength as measured by load lifted in pounds

    Maximum dumbbell load lifted successfully throughout the range of motion of a bicep curl

    Baseline, Week 7

Secondary Outcomes (21)

  • Change in voluntary activation as measured by ratio of superimposed torque to resting twitch torque

    Baseline, Week 7

  • Change in handgrip strength as measured in kilograms of force

    Baseline, Week 7

  • Change in agonist muscle activation as measured by electromyography amplitude

    Baseline, Week 7

  • Change from baseline in isokinetic muscle activation at 6 weeks

    Baseline, Week 7

  • Change in antagonist co-activation as measured by electromyography amplitude

    Baseline, Week 7

  • +16 more secondary outcomes

Other Outcomes (4)

  • Change in exercising heart rate

    Each exercise session of the 6-week intervention

  • Change in calorie consumption as measured by kilocalories determined by dietary recall

    Baseline, Week 7

  • Change in protein consumption as measured by kilocalories determined by dietary recall

    Baseline, Week 7

  • +1 more other outcomes

Study Arms (3)

Elastic Band Training

EXPERIMENTAL

This group will perform moderate intensity, whole-body elastic band training.

Behavioral: Elastic Band Training

Elastic Band Training with Maximal Mental Effort

EXPERIMENTAL

This group will perform moderate intensity, whole-body elastic band training with maximal mental effort during muscle contraction.

Behavioral: Elastic Band Training with Maximal Mental Effort

Control

NO INTERVENTION

This group will not perform any training and maintain their regular level of physical activity.

Interventions

This training intervention will be 6 weeks of moderate-intensity elastic band training, including whole-body and isolated muscle exercises.

Elastic Band Training

This training intervention will be 6 weeks of moderate-intensity elastic band training, including whole-body and isolated muscle exercises, where participants will perform maximal mental effort by imagining maximal muscle contraction during each exercise.

Elastic Band Training with Maximal Mental Effort

Eligibility Criteria

Age65 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Between 65-79 years of age
  • Female
  • Have not engaged in structured exercise for 3 years
  • Are not reliant upon a walking aid
  • Be able to rise from a chair unassisted
  • BMI between 25-33 kg/m²
  • Have access to the internet and access to a smartphone or computer with a camera at home

You may not qualify if:

  • Any history of cardiovascular, cerebrovascular, or metabolic diseases
  • Musculoskeletal injury within the past 6 months
  • Any condition affecting muscle function
  • Uncontrolled hypertension
  • Score less than 23 on the Mini-mental State Exam
  • Upon starting study, missing more than 2 training session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kennesaw State University

Kennesaw, Georgia, 30144, United States

RECRUITING

Kennesaw State University

Kennesaw, Georgia, 30144, United States

RECRUITING

Study Officials

  • Garrett Hester, Ph.D.

    Kennesaw State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Garrett Hester, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The mental effort aspect of the study will be concealed from subjects, so they will not be aware of any difference between training groups.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two intervention groups will perform different types of elastic band training, and a control group will not perform any elastic band training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Exercise Science

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 25, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations